After 10 years of continued resistance by military medicine, hyperbaric oxygen therapy has finally been shown to be more effective than ANY other treatment for traumatic brain injury, post-concussive syndrome, post-traumatic stress disorder, and concussive depression. The biggest fault of the therapy is that it works so much better than any other treatment; it is “too good to be true.” So, here is a bit of history on how the military medical hyperbaric medicine study got started, and where we are today.
Compressed air began being used to treat Caisson’s disease and diving injuries over 120 years ago. Back in 1936, 74 years ago, Behnke published the diving tables using oxygen instead of just compressed air to treat diving injuries. Oxygen diving tables were not adopted by the U.S. Navy until 1968!
Unfortunately, Hyperbaric oxygen therapy has never been taught in U.S. medical schools, and there are only a few Hyperbaric medicine fellowships. Until recently, in 2003 when the IHMA petitioned Medicare and got diabetic foot wounds approved because it prevents 75% of all amputations, Hyperbaric medicine was only available at about 500 locations. Now it is available at over 1,000 locations and increasing weekly. With it, continuing medical education is being pursued by physicians, and many more physicians today are aware of the benefits of saturating the body’s tissues with oxygen. Thanks to Congressman Istook’s efforts, Hyperbaric oxygen therapy is again receiving grants from the National Institutes of Health, and Dr. Stephen Thom has published some ground-breaking research as a result. The previous testimony to Congress, before Dr. Harch’s in 2002, was in 1963. I assure you that no other medical specialty has taken so long to tell Congress what they are able to do.
Unfortunately, though DoD developed this medicine, it has not been fully implemented to the level of known benefit to patients. This is largely because everyone “thought” they were treating bubbles as the cause of decompression sickness, the primary indication. It turned out they were generally treating damage the bubbles cause, not just bubbles. That was not discovered until 1989. Many today still believe they are treating bubbles, and this misunderstanding has held back the science and acceptance of HBOT as a therapy for general application to the repair of underlying biological processes common to many conditions.
That prejudice against hyperbaric oxygen still strongly exists in the U.S. Navy, the arm of the services charged with development of hyperbaric therapy.
1983
The Joint Advisory Commission on Clinical hyperbaric medicine is created after the U.S. Navy and U.S. Air Force get into a huge fight. To the Navy, Hyperbaric Medicine was for diving and aerospace (altitude) injuries, was very complicated, and not to be diluted to other uses. To the Air Force, the applications to burn care, to wound care, frost bite, gangrene and other applications was clear. The Navy did not want to expand hyperbaric medicine. The Air Force wanted to treat patients and further research additional applications. The Secretary of Defense intervened and gave Navy control over deployment of hyperbaric medicine throughout DoD and gave Air Force the clinical application and research role. Fred Cramer, M.D. (COL, USAF, Ret), was the first JACCHM Chair. This hostility of the Navy medical establishment toward clinical applications of hyperbaric medicine has not gone away. This Air Force research was used as the basis for the presentation to CMS on diabetic foot wounds by the IHMA’s President, Dr. Harch. Dr. Duncan, of Congressman Istook’s office, paved the way for those meetings, and CMS approved HBOT for treating diabetic foot wounds in 2003. (See every item from the first email at www.hyperbaricmedicalassociation.org.)
The following is a history and timeline of the current efforts by the lHMA to make hyperbaric oxygen the standard of care for all of its indications:
2001
Presentations by Dr. Harch sponsored by Congressman Istook’s office (Dr. Duncan) after Dr. Duncan’s military veteran son’s remarkable recovery from mTBI (a service connected injury) as a patient of Dr. Harch’s. Walter Reed Brain Injury Center (where Dr. Duncan’s son was unsuccessfully treated) attended. (CDC & SAMHSA also attended.) There were additional briefings to several NIH divisions including the National Institute of Neurological Diseases & Stroke. They met with the Director of AHRQ, Dr. John Eisenberg, who commissioned the AHRQ report (report language inserted by Mr. Istook.) Unfortunately medical politics again interfered with that report.
2001
Dr. Harch presented the acute traumatic brain injury argument to the UHMS Scientific Committee (See IHMF website under Science). The presentation followed the evidence-based medicine rules set forward by the scientific committee. Dr. Lin Weaver made the argument against adoption of this new indication. The scientific evidence was powerful, and two evidence-based medicine scales showed the treatment worked. The result was that the UHMS threw out the evidence-based medicine methodology rather than accepting the new indication. They went back to using case series reports as evidence for new indications. This halted further application of the treatment for acute traumatic brain injury and halted clinical evaluation and study into the most effective way to arrest untreated acute traumatic brain injury in society, the largest chronic disease condition, which costs society billions each year. (There are at least 30 million mild-moderate TBI patients this treatment would likely benefit, and because they do not get treatment, they have their lifetime income cut in half after their injury.)
As a result of the UHMS Scientific Committee, it was clear that the only way the science of hyperbaric medicine could advance was with the creation of a new medical society. The International Hyperbaric Medical Association was formed. Its mission is to create the future of hyperbaric medicine by winning new indications based upon science, and address key public health challenges with effective biological repair of medical conditions with hyperbaric oxygen and other adjunctive therapies. It was further contemplated that a research foundation would be created.
2001
IHMA begins discussing Diabetic Foot Wounds with the Department of Health & Human Services and the Centers for Medicare and Medicaid Services (CMS).
2002
The IHMA testifies before the House Labor-HHS-Education Appropriations subcommittee, 39 years after the first testimony about hyperbaric medicine was given. The topic was the treatment of chronic brain injury and the impact on the Federal budget. As a result, the National Institutes of Health started the hyperbaric oxygen initiative at the National Center for Complementary and Alternative Medicine (a center previously created by Dr. Duncan’s effort, which Senator Harkin made law) based upon Congressman lstook’s report language. Dr. Stephen Thom and others have received many grants as a result of that initiative.
2002
Dr. Harch, President of IHMA at the time, presents the diabetic foot wound argument to CMS. Dr. Duncan, on behalf of Mr. Istook, had four meetings with CMS to discuss the implications of the policy and the urgency of its adoption to help the federal budget. The UHMS joined the IHMA’s petition after their petition for hypoxic wounds was rejected by CMS for lack of evidence. Dr. Harch made the scientific argument and presentation to CMS. CMS approves Wagner Grade Ill wounds as reducing amputations by 75%. With Dr. Duncan’s assistance, the American Diabetes Association weighed in favorably on the application.
2003
The U.S. Navy flies Dr. Duncan to tour the Portsmouth Naval Medical Center hyperbaric center, which remains unfinished to this day. A reprogramming request of $3.14 million to complete the center had been made, and Chairman Hobson of the MilCon subcommittee blocked the request. The Chairman won and DoD medicine was not able to complete the center (see 2006 for a continuation of the story).
2004
Dr. Harch and Dr. Duncan met with Walter Reed regarding their blast injured casualties coming back from the war. Commandant at Walter Reed, COL Jonathan Jaffin, Paul Harch’s roommate at John’s Hopkins, recommended Walter Reed pay attention. They chose not to listen. Dr. Harch offered to treat 5-6 brain injured vets for free with Walter Reed performing testing before and after treatment. The offer was never accepted.
2005
Sen. Cochran tries to get hyperbaric chambers installed at Walter Reed and Bethesda. DoD medicine refuses to expend the $1 million appropriation for each hospital. (Today Walter Reed is finally putting in a wound care hyperbaric center.)
2005
HASC Chair, Duncan Hunter, convenes U.S. Military SGs offices and Tricare to have a discussion and orders that if HBOT creates a 1% improvement, it should be used. Bret Hart, CAPT, USN, who wrote the Tricare manual on Hyperbaric Medicine is disciplined for talking to Duncan Hunter at the Congressman’s request. COL Hirsh, USAF and JACCHM Chair recommends Harch’s protocol for TBI be studied. Result: After 22 years of benefit to medicine, JACCHM is dissolved by Dr. Winkenwerter, DoD SG.
2006
Navy Chief of Naval Operations, Adm. Mullen, puts $8 million into Navy budget to complete the Hyperbaric Chamber complex at Portsmouth Naval Medical Center. The Commandant of the hospital refuses to take the money despite clear evidence that it would help heal wounded warriors 50% faster with fewer surgeries. Admiral Mullen’s son was a wounded Marine there and the chief surgeon asked for his complex to be completed.
2006
U.S. Army Brigadier General is treated at Walter Reed with the Harch HBOT 1.5 80 treatment protocol and goes from making no progress for over a year with the best Walter Reed/Bethesda treatment for mTBI caused by an JED, to returning to the civilian sector as a seated judge. HBOT authorizing physician was disciplined. No others sent for treatment despite remarkable example.
2007
Congress puts $300 million into TBI/PTSD treatment research. Five HBOT studies are turned down, including one from the U.S. Air Force. In 2008, Army medicine modifies the Air Force protocol to an HBOT 2.4 1.5 hour protocol, a 3X (above HBOT 1.5) higher dose of oxygen, a dose that has been rarely used for chronic traumatic brain injury, and a dose that is higher than a dose reported to cause seizures in 9% of subjects with moderate to severe TBI.
2008
After the RAND report comes out, Dr. Duncan realized that something must be done immediately. Being “nice” to DoD medicine has not gotten the job done. Former Secretary of the Army, Martin Hoffmann, and Dr. Duncan, make 200 Hill visits telling Congress about HBOT 1.5. This results in considerable pressure on DoD Medicine, as reflected in December, 2008.
6/5/2008
Dr. Duncan meets Admiral Walsh, Vice Chief of Naval Operations. He wants to solve his retention problems. The Navy SG intervenes and through the efforts of Dr. Duncan agrees to a presentation on HBOT in blast TBI and PTSD.
8/14/2008
Dr. Harch gives a presentation at BUMED to the Navy SG, ACMAC, and other distinguished guests, requesting funding to do the pilot trial he has under submission. Dr. Harch presents his experience with the development of HBOT 1.5 ATA and the 5 U.S. servicemen with TBI and PTSD he has treated WCHM-61 thus far on this protocol. Three of five treated Cases were present and attended the lecture at their expense to testify (BG Maney, Chief Warrant Officer Fogger, and Corporal Wilson). Navy SG promises Dr. Harch funding and commissions working group that schedules a DoD Consensus Conference on HBOT in TBI.
9/2008
U.S. Air Force casualties treated with Harch HBOT 1.5 protocol and returned to duty (based upon evidence from August 14th Navy SG meeting). Savings as of January 30, 2009, were $6.3 million in retraining costs saved by stopping medical boards after HBOT and returning trained service members to duty. 80% have had recovery sufficient to return to work, duty or school (Col. Wright writes article for Military Medicine.) Military Medicine turns down the article, stating that recovery must have been due to “something else” that caused the recovery of the two airmen, despite clear evidence to the contrary. Dr. Wright is extensively published, was in charge of hyperbaric medicine research for the Air Force for many years, and is the former Brooks City AF Aerospace and Hyperbaric Medicine Fellowship Commander, training physicians.
11/2008
Harch LSU IRS-approved (#7051) pilot study begins. Results of pilot show with independent neuropsych testing 15 point IQ increases in 35 days, a 40% decrease in post-concussion syndrome, and reduced PTSD scores 30% on average, and a 51% decrease in concussive depression. The study was self-funded by Dr. Harch and supporters through veteran support groups, including the Semper Fi Fund.
12/5-6/2008
Harch Presentation at DoD Consensus Conference on HBOT for TBI Regarding LSU IRB -Approved Pilot Study Results. DoD White Paper announces that HBOT is safe, but it is ethical not to treat even though the therapy is legal and available. Dr. Harch’s pilot study slowed by obstruction within military medicine ranks, but he still freely shared all protocol information at the conference. Drs. Harch, Rockswold, Duncan, Secretary Marty Hoffmann and Steve Reimers were delegates to the DoD Consensus Conference.
The UHMS was given control of the meeting by the Department of Defense. Laurie Giselle, UHMS President, led the protocol development portion of the meeting. Drs. Harch, Rockswold and Duncan were delegates there. The entire day in the protocol meeting was spent voting down her attempts to prevent the Harch-Neubauer HBOT 1.5 protocol from even being tested. Also, at that session, Dr. Harch indicated the exact protocol for the sham section of the study, tweaking the ears with 1.2 ATA pressure at the beginning and the end, and leaving them at normobaric pressure throughout the treatment. Instead the study, which was supposed to begin March, 2009, will not start until January, 2011, and is using HBOT 1.3 for 1 hour, a dose of increased oxygen that is FDA approved for mountain sickness and was shown in the Collette study to cause patient improvement. It is a therapeutic, not a sham treatment, and this sham pressure (also used in the Air Force HBOT 2.4 TBI study) causes policy makers to reach the erroneous conclusion that HBOT has a high placebo coefficient. Oxygen, by the definition of a placebo, can never be one because it does not have the potential to be inert in the body. A conclusion that this is a placebo effect is not based upon sound science. DoD now states they will take 2.5 years but exclude Dr. Harch with his extensive experience, “claiming outside influence and undue bias” indicating that they will never let anyone see the actual treatment results from Harch’s HBOT 1.5 protocol.
12/2008
Congress provides Louisiana State University with $1.2 million for Dr. Harch to do a randomized-controlled trial on HBOT 1.5. To date, DoD medical research has refused to release Dr. Harch’s congressional appropriation. Currently the Army research director stated that it is their responsibility to protect the taxpayers. Study would be done within a few months and demonstrate with a randomized controlled trial that HBOT 1.5 works for mTBI & PTSD, as the LSU study funded with private money has already demonstrated.
12/2008
HR7299, “The TBI Treatment Act,” is introduced by Congressman Cannon (R-UT) and Congresswoman Napolitano. It is in response to Tricare refusing to pay Dr. Zant for two airmen that have been treated under prescription by COL James Wright (USAF, SOCOM Medicine). It requires DoD and VA to pay for treatment that works, when patients improve on any of four objective measures. Two months after the legislation was introduced, Tricare paid for the two airmen who recovered. (See the Wright case report in the January issue of UHM.)
2008
Secretary Hoffmann and Dr. Duncan continued to work with House and Senate members and staff, as well as meet with Department of Defense officials regarding the crisis of untreated brain injury among our war veterans.
6/2009
After 27 veterans have been treated, and numerous medical boards cancelled because of HBOT, Navy SG moves to stop sending further active duty veterans to Dr. Harch by having his staff declare that Dr. Harch treating patients is illegal, and anyone that comes to Dr. Harch must have individual waivers for gifts before they can be treated, housed, and repaired. Active duty personnel continue to be treated. This despite nearly every active duty member who was treated becoming essentially well, having medical boards cancelled, and saving the government about $2.5 million each in lifetime costs.
8/2009
IHMA launches the VA Amputation Prevention Initiative. 3,000 amputations are being done by VA each year, at a cost of $115 million. With at least 75% of those amputations being preventable, the surgical savings would be $86.5 million. Treatment with HBOT costs 1/2 of the surgery costs (less expensive if VA treats patients in their own chambers). The incoming UHMS President, Brett Hart, M.D., concurred in this initiative.
2/4/2010
Congressmen Pete Sessions, Bill Pascrell and Todd Platts reintroduce the TBI Treatment Act, now re-designated as HR 4568. Many members of Congress join as co-sponsors. It is endorsed by the Brain Injury Caucus in Congress.
3/12/2010
Dr. Harch presents data from the LSU study using HBOT 1.5 for TBI or PTSD, and demonstrates remarkable results. Hyperbaric physicians visited many of their congressional offices over 4 days to discuss how hyperbaric medicine can help solve key public health issues like amputations, and untreated brain injury.
3/15/2010
IHMA meeting with the Surgeon General of the Army and his team, to discuss the current DoD study and how the IHMA can help speed the process of treating active duty members. The Surgeon General felt that hyperbaric medicine has a high placebo effect, despite the effect of HBOT 1.5 treatments being larger than any current treatments the government is using for war veterans.
4/19/2010
A project of the International Hyperbaric Medical Foundation, The National Brain Injury Rescue and Rehabilitation Project for Mild-Moderate TBI or PTSD begins recruiting patients. See www.NBIRR.org for details.
